Intraocular Pressure After Preserflo / Innfocus Microshunt Implantation vs Trabeculectomy
PAINT
1 other identifier
interventional
70
1 country
1
Brief Summary
The aim of this project is to compare trabeculectomy with Preserflo / Innfocus Microshunt in patients with Primary Angle Open Glaucoma and Pseudoexfoliation Glaucoma regarding the reduction of intraocular pressure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2020
CompletedFirst Posted
Study publicly available on registry
June 19, 2020
CompletedStudy Start
First participant enrolled
July 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2024
CompletedJune 19, 2020
June 1, 2020
2 years
June 18, 2020
June 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in intraocular pressure
The primary endpoint is the difference between intraocular pressure after microshunt implantation vs trabeculectomy.
1 year
Study Arms (2)
Microshunt
EXPERIMENTALPatients will be treated with Preserflo / Innfocus Microshunt (Santen Pharmaceutical Co., Ltd.).
Trabeculectomy
ACTIVE COMPARATORPatients will be treated with trabeculectomy.
Interventions
The Microshunt features an 8.5-mm tube with an outer diameter of 350 µm and a 70-µm diameter lumen. Implantation creates a subconjunctival bleb and lowers intraocular pressure by increasing aqueous humor outflow.
Trabeculectomy is the most commonly performed surgical procedure and is considered the gold standard.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Primary open angle glaucoma or pseudoexfoliation glaucoma
- medically uncontrollable intraocular pressure or intolerance of topical therapy
- negative urine/serum pregnancy test of women in childbearing age
- signed and dated informed consent
You may not qualify if:
- previous incisional glaucoma procedure on affected eye
- pregnancy, nursing period
- Patients in military service, training periods and civil service
- Participation in another clinical trail
- pre-existing ocular pathologies: high myopia (refraction ≥8.00 D), thin conjunctiva
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University Innsbruck
Innsbruck, Tyrol, 6020, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2020
First Posted
June 19, 2020
Study Start
July 22, 2020
Primary Completion
July 22, 2022
Study Completion
July 22, 2024
Last Updated
June 19, 2020
Record last verified: 2020-06